Senior Validation Specialist

Bayer; Warszawa; Hybrid; PLN 206,000 - 246,000; Full time

Benefits offered by this job

Medical care above statutory

Flexible benefits

Life insurance

Pension plans

Home office allowance

Extra paid holidays

Job summary

Bayer Warsaw is seeking a Senior Validation Specialist to lead validation of the Integration Mesh platform, ensuring GxP compliant operations and documentation. You will guide the team, develop validation plans, and align with quality and cross-functional stakeholders.

The role focuses on system validation, lifecycle documentation, audits, and adopting best practices in a dynamic data analytics environment within Bayer Consumer Health.

Qualifications

• Bachelor’s degree in Computer Science, Technology, or a related field.
• Minimum of 7+ years of experience in validation of computer systems within the pharmaceutical or medical device industries with prior experience in leading validation projects.
• Strong IT background with experience working with or validating foundational technical platforms and system integration.
• Familiarity with AI and AI-augmented tooling is a plus.
• Proven ability to communicate effectively, both verbally and in writing and ability to guide junior team members.

Responsibilities

• Lead the validation work and the validation team for the whole integration Mesh platform, plan timelines, and work of the team, and align with the quality team.
• Develop, review, and execute validation plans for computer systems in compliance with regulatory requirements.
• Ensure that all validation documentation is accurate, complete, and in accordance with SOPs and policies.
• Collaborate with cross-functional teams to identify validation requirements and ensure successful implementation.
• Create change requests and conduct risk assessments and impact analyses to determine validation approaches for global and local systems.

Skills

Leadership

GxP knowledge

Communication skills

Validation planning

Problem solving

Education

Bachelor’s degree in Computer Science or related field

Tools

AWS SQS

AWS Lambda

Terraform

Node.js

GitHub

Job description

At Bayer, we are committed to transparency, equal pay for equal work or work of equal value, and objective reward practices in line with EU and local regulations.

The minimum monthly gross compensation for this role is 20 240 PLN gross with final pay determined based on objective factors such as experience, qualifications, scope of responsibility, and internal alignment.

This position is eligible for variable pay components, such as performance-based bonuses, awarded in accordance with the applicable employee group, role scope, and compensation structure.

In addition, Bayer offers a competitive and holistic benefits package, including:

• Medical care above statutory requirements
• Flexible benefits supporting leisure, and well-being/sports programs
• Life, accident, and disability insurance through group coverage
• Employer-supported pension plans with regular company contributions
• Home office allowance to support hybrid or remote work
• Extra Paid Holidays

Benefits may vary depending on country, role, and employment conditions.

For Digital Hub Warsaw, we are looking for:

Senior Validation Specialist

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ‘Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

The Data Assets, Analytics & AI team at Bayer Consumer Health focuses on bringing digital transformation and innovation by creating best in class analytical solutions enabling data-driven decision making and performance optimization for Bayer Consumer Health organization.

You will be part of the Data Assets, Analytics & AI organization and are responsible to lead the validation of our system integration platform called Integration Mesh. In that role, you will be responsible to lead the GxP validation process new platform components and enhancements. In additional you will ensure a GxP compliant operation. This includes planning, execution, documentation. In additional you will contribute to standards and best practices in the validation community. If you are interested in joining a young and dynamic team driving the digital transformation of Bayer Consumer Health, we would like to hear from you.

Key Responsibilities

• Lead the validation work and the validation team for the whole integration Mesh platform, plan timelines, and work of the team, and align with the quality team
• Develop, review, and execute validation plans for computer systems in compliance with regulatory requirements.
• Ensure that all validation documentation is accurate, complete, and in accordance with organizations standard operating procedures and policies.
• Collaborate with cross-functional teams to identify validation requirements and ensure successful implementation.
• Create the Change requests and conduct risk assessments and impact analyses to determine the validation approach for various systems that are Global and local.
• Guide the team in writing and reviewing system lifecycle documents such as requirements, technical specifications and other general documents related to CSV.
• Write and review protocols, reports, and other related documents for IT systems in the context of validation.
• Initiate and handle approval workflows for CSV deliverables in Bayer document management systems.
• Work with global and local sites in cases where the system or module is a global or local system/module.
• Act as a Subject Matter Expert (SME) for the Document Management System (DMS) to support queries from cross-functional teams or during audits.
• Provide guidance and support to junior team members regarding validation best practices and methodologies.
• Stay updated on industry trends, regulatory changes, and advancements in validation technologies, including AI and digital solutions.
• Participate in audits and inspections, lead them from Integration Mesh perspective, providing necessary documentation and insights as required.
• Support in creating and updating training materials for systems in scope to support business.

Qualifications

• Bachelor’s degree in Computer Science, Technology, or a related field.
• Minimum of 7+ years of experience in validation of computer systems within the pharmaceutical or medical device industries with prior experience in leading validation projects.
• Strong IT background with experience working with or validating of foundational technical platforms (platform engineering), distributed systems architectures (such as microservices) and system integration (technologies such as APIs, message brokers, stream processing). Familiarity with the platforms main technologies & programming languages: AWS SQS, AWS Lambda, Terraform, Node.js, GitHub. Familiarity with AI and AI-augmented tooling is a plus.
• Proven ability to communicate effectively, both verbally and in writing and ability to guide junior team members.
• Experience in writing validation plans and other CSV-related documentation.
• Strong analytical and problem-solving skills attention to details when it comes to CSV documents.
• Ability to work independently and as part of a team in a fast-paced environment.

Location

Poland : Mazowieckie : Warszawa

Division

CH DAA&AI

Reference Code

878670